FDA Approves Merz’s Xeomin for Fourth Neurological Indication
Xeomin, a botulinum toxin similar to Botox that is used cosmetically to smooth frown lines between the eyebrows, is becoming an ever more versatile product for Raleigh-based Merz North America.
The U.S. Food and Drug Administration has approved Xeomin to treat chronic sialorrhea, or excessive drooling, in adults.
“Until now, there has not been an FDA-approved treatment for this debilitating condition,” said Kevin O’Brien, vice president and U.S. head of neurosciences for Merz North America. “This approval represents a significant milestone in addressing the unmet needs for more than 600,000 adults who suffer from chronic sialorrhea, and underscores our commitment to improving the lives of those living with movement disorders.”
Sialorrhea is a common symptom of patients who’ve had a stroke or suffer from neurological disorders including Parkinson's disease, amyotrophic lateral sclerosis or cerebral palsy. It can occur from difficulty retaining saliva inside the mouth, issues with swallowing and from problems controlling facial muscles.
The FDA approved Merz’s supplemental Biologics License Application (sBLA) for Xeomin after granting the application a priority review designation. Priority reviews are given to drugs that will potentially provide significant improvements in the safety and effectiveness of the treatment, diagnosis or prevention of serious conditions.
The FDA approval was based on a Phase III clinical trial of 184 patients that showed Xeomin brought a statistically significant improvement in unstimulated salivary flow rate and Global Impression of Change Scale (GICS) compared to baseline pre-injection measures. GICS is a commonly used rating system for treatments of neurological disorders by clinicians.
This is the fourth neurological indication approved for Xeomin in adult patients, in addition to its use in aesthetic procedures. Xeomin was first approved by the FDA in 2010 for the treatment of cervical dystonia, a painful condition in which the neck muscles contract involuntarily, causing the head to twist or tilt uncontrollably, and blepharospasm, an involuntary closing or twitching of the eyelid. In 2015 Xeomin was approved for treating upper limb spasticity.
Xeomin works by temporarily blocking nerve signals that cause muscles to contract. Unable to contract, the muscles relax and smooth.
Merz contracted with supermodel, actress and entrepreneur Christie Brinkley in 2017 to help market the cosmetic use of Xeomin for smoothing frown lines.
Merz North America is a division of privately owned Merz Pharma, an international specialty health care company based in Frankfurt, Germany, that is focused on aesthetics and neuroscience products to help patients “live better, feel better and look better.”
Nearly 300 employees of Merz North America celebrated the 110th anniversary of Merz’s founding in June at the company’s offices on Six Forks Road in North Raleigh.
Merz established its North America division in Greensboro in 1995 and kept it there until January 2015, when it consolidated operations at a 60,000 square-foot facility in Raleigh.
In 2017 Merz reported $1.2 billion in global revenues, about a third coming from U.S. sales. It spent about $176 million on research and development.